- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00994318
Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (FIND-CKD)
An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject High and Low Dosage Regimens) Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease
Study Overview
Status
Conditions
Detailed Description
After an initial screening period of up to 4 weeks, eligible subjects were randomised (1:1:2) to 1 of the following 3 treatment arms for a period of 52 weeks.
- FCM regimen (maximum single intravenous doses of 1,000 mg of iron) targeting a ferritin level of 400-600 mcg/L.
- FCM regimen (maximum single intravenous doses of 200 mg of iron) targeting a ferritin level of 100-200 mcg/L.
- Daily oral iron with 200 mg iron/day (100 mg twice daily)
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Gosford, Australia, 2250
- Gosford Hospital - Renal Research
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Innsbruck, Austria, 6020
- Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin IV
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Baudour, Belgium, 7331
- RHMS Baudour - Department of Nephrology and Dialysis
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Novy Jicin, Czech Republic, 74101
- Nemocnice s poliklinikou v Novem Jicine, p.o. p.o. Interni oddeleni - nefrologie a dialyza
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Frederica, Denmark, 7000
- Lillebalt Frederica Sygehus Department of Nephrology
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Grenoble Cedex, France, 38043
- CHU grenoble - Service de Nephrologie
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Demmin, Germany, 17109
- Praxis Dr. Kraatz
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Arta, Greece, 47100
- General Hospital of Arta - Nephrology Department
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Anzio, Italy, 00042
- Ospedali Riuniti Anzio-Nettuno ASL ROMA H U.O. Nefrologia e Dialisi
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Amersfoort, Netherlands, 3816 CP
- Meander Medisch Centrum - Locatie Amersfoort Lichtenberg
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Trondheim, Norway, 7006
- St. Olav's Hospital
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Warszawa, Poland, 04-749
- Miedzyleski Szpital Spec. Oddzial I Wewnetrzny I Nefrologii
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Lisboa, Portugal, 1649-035
- Hospital Santa Maria - Nefrologia
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Bucuresti, Romania, 010731
- Spitalul Clinic de Nefrologie"Dr Carol Davila"
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Santander, Spain, 39008
- Hospital Universitario Marqués de Valdecilla - Servicio de Nefrología
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Stockholm, Sweden, 141
- Karolinska University Hospital
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Adana, Turkey, 01330
- Cukurova University Medical Faculty Balcali Hospital - Department of Nephrology
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London, United Kingdom, SE5 9RS
- King's College Hospital
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North Carolina
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Wilmington, North Carolina, United States, 28401
- Trial Management Associates
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 18 years of age.
- NDD-CKD subjects with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m2 using modification of diet in renal disease 4 (MDRD-4) calculation.
- NDD-CKD subjects with an eGFR loss ≤12 mL/min/1.73 m2/year and a predicted eGFR of ≥15 mL/min/1.73 m2 in 12 months.
- Any single Hb between 9 and 11 g/dL within 4 weeks of randomisation. A value taken as part of routine medical care was used.
- Any single serum ferritin <100 mcg/L or <200 mcg/L with TSAT <20% within 4 weeks of randomisation. Measurements taken as part of routine medical care were used.
- ESA naïve; no exposure to ESA in last 4 months prior to randomisation.
- Females of childbearing potential must have had a negative pregnancy test, using any medically acceptable assessment, prior to randomisation.
- Before any study specific procedure, the appropriate written informed consent must have been obtained.
Exclusion Criteria:
- History of acquired iron overload.
- Known hypersensitivity reaction to any component of ferrous sulphate or FCM. Subjects with hypersensitivity to other forms of iron were permitted to participate.
- Documented history of discontinuing oral iron products due to significant gastrointestinal (GI) distress.
- Screening TSAT >40%.
- Known active infection, C-reactive protein >20 mg/L, clinically significant overt bleeding, active malignancy (i.e., clinical evidence of current malignancy or not in stable remission for at least 5 years since completion of last treatment with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia).
- History of chronic alcohol abuse (alcohol consumption >40 g/day).
- Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range.
- Active human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome or active hepatitis B or C virus infection.
- Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects with treated Vitamin B12 or folic acid deficiency were permitted.
- IV iron and/or blood transfusion in previous 30 days prior to screening (or during the screening period).
- Oral iron therapy at doses >100 mg/day dosing must have been discontinued at least 1 week prior to randomisation. If subject had received this therapy for >3 months (at doses >100 mg/day) then subject was not eligible. Ongoing use of multivitamins containing iron was permitted.
- Immunosuppressive therapy that may have led to anaemia (e.g., cyclophosphamide, azathioprine, or mycophenolate mofetil). Steroid therapy was permitted.
- Currently requiring renal dialysis.
- Anticipated dialysis or transplant during the study.
- Anticipated need for surgery that may have resulted in significant bleeding (>100 mL).
- Currently suffering from chronic heart failure New York Heart Association Class IV.
- Poorly controlled hypertension (>160 mmHg systolic pressure or >100 mmHg diastolic pressure).
- Acute coronary syndrome or stroke within the 3 months prior to screening.
- Currently suffering from concomitant, severe psychiatric disorders or other conditions which, in the opinion of the Investigator, would have made participation unacceptable.
- Subject was not using adequate contraceptive precautions.
- Subject of childbearing potential was evidently pregnant (e.g., positive human chorionic gonadotropin test) or was breast feeding.
- Body weight <35 kg.
- Subject currently was enrolled in or had not yet completed at least 30 days since ending other investigational device or drug studies, or subject was receiving other investigational agent(s).
- Subject would not be available for follow-up assessment.
- Subject had any kind of disorder that compromised the ability of the subject to give written informed consent and/or to comply with study procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: FCM (high ferritin target)
Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
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Other Names:
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Experimental: FCM (low ferritin target)
Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
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Other Names:
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Active Comparator: Oral Iron
Ferrous sulphate 100 mg iron twice daily, continuous
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger
Time Frame: Up to 1 year after baseline
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Endpoint reported number of participants with/without events and was reached:
Sensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management:
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Up to 1 year after baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Iain Macdougall, King's College Hospital NHS Trust
Publications and helpful links
General Publications
- Roger SD, Gaillard CA, Bock AH, Carrera F, Eckardt KU, Van Wyck DB, Cronin M, Meier Y, Larroque S, Macdougall IC; FIND-CKD Study Investigators. Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial. Nephrol Dial Transplant. 2017 Sep 1;32(9):1530-1539. doi: 10.1093/ndt/gfw264.
- Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Meier Y, Larroque S, Roger SD; FIND-CKD Study investigators. Renal function in patients with non-dialysis chronic kidney disease receiving intravenous ferric carboxymaltose: an analysis of the randomized FIND-CKD trial. BMC Nephrol. 2017 Jan 17;18(1):24. doi: 10.1186/s12882-017-0444-6.
- Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Roubert B, Nolen JG, Roger SD; FIND-CKD Study Investigators. FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant. 2014 Nov;29(11):2075-84. doi: 10.1093/ndt/gfu201. Epub 2014 Jun 2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FER-CKD-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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